Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on August 07, 2026 and include a total of 17860 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-1446-2019 | 05-06-2019 | Pramipexole Dihydrochloride Tablets 0.5 mg, 90-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-198-16 | CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. | Zydus Pharmaceuticals USA Inc / 168,330 90-count bottles | Class II | Terminated |
| D-1436-2019 | 05-06-2019 | Senna (sennosides 8.8 mg) Syrup, 8 fl oz. (237 mL) bottles, Rij Pharmaceuticals Corporation 40 Commercial Avenue, Middletown, NY 10941, NDC 53807-556-08 | Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported | Geritrex, LLC / 1536 units | Class II | Terminated |
| D-1437-2019 | 05-06-2019 | Senna (sennosides 8.8 mg) Syrup 8 fl oz. (236 mL) bottles, Distributed by Geritrex, LLC 40 Commercial Avenue Middletown, NY 10941, NDC 54162-007-08 | Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported | Geritrex, LLC / 24312 units | Class II | Terminated |
| D-1289-2019 | 05-03-2019 | Losartan Potassium Tablets USP 50 mg 90 film coated tablets Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816. 1-866-901-DRUG (3784) NDC 23155-645-09 | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer | Heritage Pharmaceuticals, Inc. / 34403 bottles | Class II | Terminated |
| D-1290-2019 | 05-03-2019 | Losartan Potassium Tablets USP 100 mg 1000 film coated tablets Rx only Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816. 1-866-901-DRUG (3784) NDC 23155-646-10 | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer | Heritage Pharmaceuticals, Inc. / 3697 bottles | Class II | Terminated |
| D-1308-2019 | 05-03-2019 | Bevacizumab 2.5 mg/0.1 mL, packaged in a Prefilled Syringe, Rx only, AVELLA SPECIALTY PHARMACY 24416 N. 19TH AVENUE PHOENIX, AZ 85085, NDC 42852-001-27 | Lack of assurance of sterility | Avella of Deer Valley, Inc. Store 38 / 730 syringes | Class II | Terminated |
| D-1288-2019 | 05-03-2019 | Losartan Potassium Tablets USP 100 mg 90 film coated tablets Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816. 1-866-901-DRUG (3784) NDC 23155-646-09 | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer | Heritage Pharmaceuticals, Inc. / 25220 bottles | Class II | Terminated |
| D-1291-2019 | 05-03-2019 | Losartan Potassium Tablets USP 25 mg 90 film coated tablets Rx Only Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816. 1-866-901-DRUG (3784) NDC 23155-644-09 | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer | Heritage Pharmaceuticals, Inc. / 15541 bottles | Class II | Terminated |
| D-1287-2019 | 05-03-2019 | Losartan Potassium Tablets, USP 50 mg 1000 film coated tablets Rx Only Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816. 1-866-901-DRUG (3784) NDC 23155-645-10 | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer | Heritage Pharmaceuticals, Inc. / 3012 bottles | Class II | Terminated |
| D-1307-2019 | 05-02-2019 | Articaine DENTAL, Articane hydrochloride 4% and epinephrine 1:100,000, 50 cartridges. 1.7 mL each, Rx only, Manufactured for: DENTSPLY Pharmaceutical, by Novocol Pharmaceutical of Canada, Inc. York, PA 17404, NDC 66312-601-16 Reorder #: 51116 Package NDCs: 66312-601-16; 66312-602-16 | Labeling: Not Elsewhere Classified. This recall has been initiated due to mislabeling. The printed carton used in manufacturing both batches contained text for both 2% Xylocaine DENTAL and Articadent DENTAL. Xylocaine DENTAL is a trade name for Lidocaine HCL 2% and Epinephrine 1: 100,000 formulation, while Articadent DENTAL is a trade name for Articaine HCI 4% and Epinephrine 1 :100,000. The cartridges contained within the printed carton are labeled appropriately as Articadent DENTAL. | Septodont Inc. / 240 cartons of 50 glass cartridges each | Class II | Terminated |
| D-1302-2019 | 05-02-2019 | CVS Health Children's Cough Syrup English Ivy Leaf Daytime Relief Natural Pineapple Flavor 20 Single-Use 0.08 fl. oz. (2.5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, UPC 050428597958 | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia. | Unipharma, Llc. / 38640 cartons | Class II | Terminated |
| D-1303-2019 | 05-02-2019 | DrKids Children's Natural Cough Syrup English Ivy Leaf Organic Agave Nectar Pre-measured Single-Use 0.17 fl. oz. (5 mL), Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, UPC 370302489019 | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia. | Unipharma, Llc. / 39216 cartons | Class II | Terminated |
| D-1299-2019 | 05-02-2019 | DrKids Children's Pain & Fever Oral Solution Acetaminophen 160 mg/5 mL, 20 Pre-measured Single-Use Vials 0.17 fl. oz. (5 mL), Cherry Flavor, Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, NDC 70302-011-20, UPC 370302223019 | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia. | Unipharma, Llc. / 280 cartons | Class II | Terminated |
| D-1301-2019 | 05-02-2019 | DrKids Children's Cough & Chest Congestion DM, Dextromethorphan HBr 5 mg Guaifenesin 100 mg Mixed Berry Flavor 20 Pre-measured Singe-Use 0.17 fl. oz. (5 mL), Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, NDC 70302-013-20, UPC 370302268010 | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia. | Unipharma, Llc. / 1344 cartons | Class II | Terminated |
| D-1298-2019 | 05-02-2019 | DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistamine, 20 Pre-measured Single-Use Vials, 0.17 fl. oz. (5 mL), Mixed Berry, Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, NDC 70302-012-20, UPC 370302255010 | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia. | Unipharma, Llc. / 1060 cartons | Class II | Terminated |
| D-1297-2019 | 05-02-2019 | CVS Health Children's Mucus Relief Chest Congestion Plus Cough Dextromethorphan HBr Cough Suppressant Guaifenesin Expectorant Mixed Berry Flavor 20 Singe-Use Vials Per Carton 0.17 fl. oz. (5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, NDC 69842-260-01, UPC 050428597675 | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia. | Unipharma, Llc. / 33360 cartons | Class II | Terminated |
| D-1305-2019 | 05-02-2019 | DrKids Himasal Natural Nasal Saline Solution with Himalayan Salt, 20 count Single-Use Vials, Drug Free, Manufactured by: Unipharma, LLC. Tamarac, FL 33321, a) 0.02 fl. oz. (0.5 mL), UPC 370302446081; b) 0.05 fl. oz. (1.5 mL), UPC 370302446098 | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia. | Unipharma, Llc. / 816 cartons | Class II | Terminated |
| D-1296-2019 | 05-02-2019 | CVS Health Children's Pain & Fever Acetaminophen 160 mg/5 mL Pain reliever/Fever reducer Single-Use Vials Cherry Flavor 20 Single-Use Vials per carton 0.17 fl. oz. (5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, NDC 69842-0258-01, UPC 050428601891 | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia. | Unipharma, Llc. / 15264 cartons | Class II | Terminated |
| D-1304-2019 | 05-02-2019 | CVS Health Children's Nasal Saline Drops With Himalayan Salt Saline Nasal Moisturizer Single-Use 30 Single-Use 0.05 fl. oz. (1.5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, UPC 050428598207 | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia. | Unipharma, Llc. / 23712 cartons | Class II | Terminated |
| D-1300-2019 | 05-02-2019 | CVS Health Children's Allergy Relief Liquid Medication Diphenhydramine HCl 12.5 mg/5 mL Oral Solution Antihistamine Mixed Berry Flavor 20 Single-Use 0.17 fl. oz. (5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, NDC 69842-261-01, UPC 050428597156 | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia. | Unipharma, Llc. / 27840 cartons | Class II | Terminated |
| D-1306-2019 | 05-02-2019 | CVS Health Children's Cough & Chest Congestion DM Dextromethorphan HBr, 5 mg Cough Suppressant Guaifenesin, USP 100 mg Expectorant Mixed Berry Flavor 20 Single-Use Vials 0.17 fl. oz. (5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895,NDC 69842-262-01, UPC 050428598368 | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia. | Unipharma, Llc. / 21456 cartons | Class II | Terminated |
| D-1283-2019 | 05-01-2019 | Losartan Potassium Tablets USP 25 mg 90 count bottle NDC 60429-316-90 Rx only GSMS Incorporated | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer | Golden State Medical Supply Inc. / 64,362 HDPE bottles | Class II | Terminated |
| D-1284-2019 | 05-01-2019 | Losartan Potassium Tablets USP 25 mg 1000 count bottle NDC 60429-316-10 Rx only GSMS Incorporated | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer | Golden State Medical Supply Inc. / 11,286 HDPE Bottles | Class II | Terminated |
| D-1286-2019 | 05-01-2019 | Losartan Potassium Tablets USP 100 mg 1000 count bottle NDC 60429-318-10 Rx only GSMS Incorporated | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer | Golden State Medical Supply Inc. / 8,767 HDPE Bottles | Class II | Terminated |
| D-1285-2019 | 05-01-2019 | Losartan Potassium Tablets USP 100 mg 90 count bottle NDC 60429-318-90 Rx only GSMS Incorporated | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer | Golden State Medical Supply Inc. / 138,213 HDPE Bottles | Class II | Terminated |
| D-1282-2019 | 05-01-2019 | Losartan Potassium Tablets USP 25 mg 30 count bottle NDC 60429-316-30 Rx only GSMS Incorporated | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer | Golden State Medical Supply Inc. / 11,668 HDPE bottles | Class II | Terminated |
| D-0018-2021 | 04-30-2019 | Losartan Potassium 100 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 61919-952-30 | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level per manufacturer | Direct Rx / 33 bottles | Class II | Terminated |
| D-1274-2019 | 04-30-2019 | Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), 2 mL Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195, NDC: 25021-701-02 Package NDCs: 25021-700-01; 25021-701-01; 25021-701-02 | Lack of Sterility Assurance: Microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products. | Sagent Pharmaceuticals Inc / 75,825 vials | Class II | Terminated |
| D-1293-2019 | 04-30-2019 | Mycophenolate Mofetil for Injection, USP 500 mg, 4 Single Dose Vials, Rx Only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC 342023-172-044 Package NDCs: 42023-172-04 | Presence of Particulate Matter; glass fragment observed in one vial of reconstituted product | Par Pharmaceutical, Inc. / 4506 packs | Class I | Terminated |
| D-1281-2019 | 04-30-2019 | Losartan Potassium Tab. USP 50mg, a) 30 count bottle (NDC 68788-0048-03) and b) 90 count bottle (NDC 68788-0048-09), Rx only, Preferred Pharmaceuticals, Inc., Anaheim, CA, Mfg: Torrent Pharma Inc., Basking Ridge, NJ | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer | Preferred Pharmaceuticals, Inc / | Class II | Terminated |
| D-1278-2019 | 04-29-2019 | Relpax (eletriptan HBr) 40 mg, a) 12 tablets 2 cards x six 40 mg tablets per blister pack, NDC 0049-2340-05; b) 6 tablets 1 card x six 40 mg tablets per blister pack, NDC 0049-2340-45, Rx Only, Made in Ireland, Distributed by Roerig, Division of Pfizer Inc, NY NY 10017. | Labeling: Label Error on Declared Strength: an artwork error on the secondary packaging of Relpax 40 mg Tablets, indicates that each tablet contains eletriptan hydrobromide equivalent to 20mg eletriptan, instead of 40mg, on one side of the carton. | Pfizer Inc. / 100277 tablets | Class III | Terminated |
| D-1251-2019 | 04-26-2019 | HYDROmorphone 20 mg/100 mL Injectable Solution, Hydromorphone HCl 20 mg 0.9% Sodium Chloride 100 mL, Sterile single use bag, Compounded Drug, Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404, NDC: 42852-221-10 | Sub-potency | Advanced Pharma Inc. / 560 bags | Class II | Terminated |
| D-1275-2019 | 04-25-2019 | Revonto (dantrolene sodium for injection), 20 mg/vial, For treatment of malignant hyperthermia, For Intravenous Use Only, Rx Only, Made in Italy, Dist. by: US WorldMeds, LLC, Louisville, KY 40241, NDC: 27505-003-67 | Presence of Precipitate: Appearance is Out of Specification for the reconstituted solution during 24-month stability time point analysis. | US Worldmeds LLC / 6456 vials | Class II | Terminated |
| D-1279-2019 | 04-25-2019 | Dermoplast Anesthetic PAIN & ITCH (benzocaine and menthol) SPRAY canisters, 20%, 0.5%, Net WT 2.75 oz (78g); Distributed by Moberg Pharma North America LLC, Cedar Knolls, NJ 07927; UPC 8 51409 00722 6 | Labeling: Not Elsewhere Classified: canisters incorrectly state the net weight is 2.75 oz. rather than the correct net weight of 2.0 oz. | Advantice Health / 111,492 canisters total | Class III | Terminated |
| D-1280-2019 | 04-25-2019 | Dermoplast Anesthetic PAIN & ITCH (benzocaine and menthol) SPRAY canisters, 20%, 0.5%; full case of 12-2 oz. cans only; Distributed by Moberg Pharma North America LLC, Cedar Knolls, NJ 07927; Product Code 80-6802; Case UPC 1 03 16864 68002 7. | Labeling: Not Elsewhere Classified: Full cases may contain canisters that incorrectly state the net weight is 2.75 oz. rather than the correct net weight of 2.0 oz. | Advantice Health / 111,492 canisters total | Class III | Terminated |
| D-1273-2019 | 04-25-2019 | Carvedilol Tablets, USP, 6.25 mg, 500 count bottles, Rx Only Manufactured by: Cadila Healthcare Ltd., India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ USA 08534 NDC 68382-093-05 Package NDCs: 68382-092-17; 68382-092-01; 68382-092-05; 68382-093-17; 68382-093-05; 68382-093-01; 68382-094-17; 68382-094-01; 68382-094-05; 68382-095-17; 68382-095-01; 68382-095-05 | Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg | Zydus Pharmaceuticals USA Inc / 3900 | Class II | Terminated |
| D-1272-2019 | 04-25-2019 | Acyclovir Tablets, USP, 400 mg, 100 count bottles, Rx Only Manufactured by: Cadila Healthcare Ltd., India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ USA 08534 NDC 68382-791-01 Package NDCs: 68382-791-06; 68382-791-16; 68382-791-01; 68382-791-05; 68382-791-10; 68382-791-30; 68382-792-06; 68382-792-16; 68382-792-01; 68382-792-05; 68382-792-10; 68382-792-30 | Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg | Zydus Pharmaceuticals USA Inc / N/A | Class II | Terminated |
| D-1263-2019 | 04-24-2019 | Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: The Kroger Co, Cincinnati, OH 45202, Manufactured for: Torrent Pharma Inc., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045 NDC 68645-494-54 | CGMP Deviations: Detection of trace amounts of N-Methylnitrosobutyric acid (NMBA) impurity found in the Active Pharmaceutical Ingredient (API) | Legacy Pharmaceutical Packaging LLC / 60,012 bottles | Class II | Ongoing |
| D-1250-2019 | 04-24-2019 | Losartan Potassium Tablets USP 25 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-516-15 Manufactured for: AvKARE Inc. Pulaski, TN 38478 | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million. | AVKARE Inc. / 846 cartons (42,300 tablets) | Class II | Ongoing |
| D-1249-2019 | 04-24-2019 | Losartan Potassium Tablets USP 50 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-517-15 Manufactured for: AvKARE Inc. Pulaski, TN 38478 | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million. | AVKARE Inc. / 1438 cartons (71,900 tablets) | Class II | Ongoing |
| D-1583-2019 | 04-24-2019 | DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, USP Tablets, 250 mg, 100 count-unit dose carton, RX only, Manufactured by Dr. Reddy's Laboratories Ltd. Bachupally - 500 090 India. Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152. NDC # 0904-6363-61. Package NDCs: 0904-6363-45; 0904-6363-61 | cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations. | MAJOR PHARMACEUTICALS / 828 100-count unit dose cartons | Class II | Terminated |
| D-1241-2019 | 04-23-2019 | Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 25 Ampules per carton, (2 mL each), Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-030-25 | Failed impurities/degradation specification: Out of Specification result for total impurity at 4.0% (Limit: NMT 3.0%) at 12 months stability testing. | Akorn Inc / 5,380 cartons (25 ampules per carton) | Class III | Terminated |
| D-1292-2019 | 04-23-2019 | Titanium 4000, capsule, 4000 mg, 1 count blister card, 30 blister display boxt, distributed by Titanium 4000 UPC 86077000020 | Marketed without an approved NDA/ANDA: undeclared sildenafil and tadalafil. | D.B.P. Distribution / unknown | Class I | Terminated |
| D-1316-2019 | 04-22-2019 | Mild Health Care Antibacterial Hand Soap, .6% P.C.M.X., packaged in a) 1000 ml Disc Pump pouches, 8 x 1000 ml Disc Pump pouches per case, 5013-L1000, b) 2000 ml. Disc Pump pouches, 4 x 2000 ml Disc Pump pouches per case, 5013-XL2000, c) 800 ml Universal Valve pouches, 12 x 800 ml Universal Valve pouches per case, 5013-404, d) 1 gallon bottles, 4/1 gallon bottles per case, 5013-420-02, INOPAK, LTD., 24 Executive Parkway, Ringwood, NJ 07456. | CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices. | Inopak Ltd / 17,850 pounds per batch | Class II | Terminated |
| D-1313-2019 | 04-22-2019 | INODERM Antiseptic Hand Soap (E-2), .6% (incorrectly labeled on bags as 75%) PCMX, 800ml/27fl.oz.pouches (NDC 058575-110), 12 x 800 Bag-N-Box pouches per case (NDC 058575-110-80), 5014-404-NB; INOPAK, 24 Executive PKWY, Ringwood, NJ 07456. | CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices. | Inopak Ltd / 17,850 pounds per batch | Class II | Terminated |
| D-1315-2019 | 04-22-2019 | Antibacterial Hand Soap, Healthcare 2000, labeled as a) DERMA System CARE SaniClenz Antimicrobial Skin Cleanser (Chlorhexidine Gluconate), 4 x (1 gallon containers), Reorder/REF #JSCG; Manufactured for Crosstex International, Inc.; b) MEDI-WASH CHG Anti-Microbial Hand Wash with Chlorhexidine Gluconate; 1000ML pouches, 8/1000ML pouches per case, Walter G. Legge Co Inc, 444 Central AVE, Peekskill, NY 10566 | CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices. | Inopak Ltd / 17,850 pounds per batch | Class II | Terminated |
| D-1242-2019 | 04-22-2019 | Carvedilol Tablets, USP, 3.125 mg, 500-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd., India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; NDC 68382-092-05 Package NDCs: 68382-092-17; 68382-092-01; 68382-092-05; 68382-093-17; 68382-093-05; 68382-093-01; 68382-094-17; 68382-094-01; 68382-094-05; 68382-095-17; 68382-095-01; 68382-095-05 | Presence of Foreign Tablets/Capsules: Customer complaint for a small, solid, light yellow substance, identified as a fragmented tablet of another drug product, found mixed with tablets in a bottle of Carvedilol tablets 3.125mg. | Zydus Pharmaceuticals USA Inc / 7668 bottles | Class III | Terminated |
| D-1270-2019 | 04-22-2019 | Losartan Potassium/HCTZ, 100 mg/12.5 mg Tablet, 90-Count bottle, Manufactured by Torrent Pharmaceuticals, Distributed by RemedyRepack, Inc. Indiana, PA, 15701-3570, NDC 70518-1560-00. | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million. | RemedyRepack Inc. / 44 HDPE bottles of 90 = 3,960 tablets | Class II | Terminated |
| D-1312-2019 | 04-22-2019 | Instant Waterless Hand Sanitizer, Ethyl Alcohol, 62%, packaged as a) DermaGel Instant Waterless Hand Sanitizing Gel with Moisturizers, with Aloe Vera & Vitamin E, packaged in a) 1000 ml Disc Pump pouches (NDC 58575-340), 8 x 1000 ml Disc Pump pouches per case, Product Code 5025-L1000; b) 2 fl. oz. bottles, 80/2 oz bottles per case, 5025-480-02; c) 18 fl. oz. bottles (NDC 58575-340), 16/18 oz bottles per case, 5025-430-02; d) 8 FL OZ. bottle, 24/8 oz bottle per case, 5025-440-03; e) 4 fl. oz. bottles, 24 x 4oz. Bottles per case, 5025-450-03; f) 800 ml pouches, 12 x 800 ml Universal Valve pouches per case, 5025-404-NB; g) 1 Gallon bottles, 4/1 gallon bottles per case, 5025-4202-02; Inopak LTD., Ringwood, NJ 07456. SaniTyze Hand Sanitizer with Aloe Vera, Vitamin E & Keratin, packaged as h) 8 fl oz (237 ml) bottles, 24/ 8 Oz. bottles per case; Manufactured for Crosstex International, Inc., 10 Rarick Road, Hauppague, NY 11788-4209. | CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices. | Inopak Ltd / 17,850 pounds per batch | Class II | Terminated |
| D-1317-2019 | 04-22-2019 | Sani-Guard-SF Waterless Foam Hand Sanitizer, Ethyl Alcohol 70%, packaged in a) 6/1000 ml pouches per case, 5068-FL1000, b) 1000 ml cartridge pouch, 6/1000 ml .8ml Option Cartridge pouches per case, 5068-OS1000, Inopak LTD | CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices. | Inopak Ltd / 17,850 pounds per batch | Class II | Terminated |
| D-1314-2019 | 04-22-2019 | INOFOAM Foaming E-2 Food Handling Wash with .6% PCMX, 1000mL pouch (NDC 058575-110-11), 6/1000 ML pouches per case (NDC 058575-110-80), 5064-FL1000, Inopak, LTD. | CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices. | Inopak Ltd / 17,850 pounds per batch | Class II | Terminated |
| D-1310-2019 | 04-22-2019 | ANTIBACTERIAL Foaming Hand Wash With Moisturizers labeled as Antibacterial Foaming Soap, ACTIVE:P.C.M.X, packaged in a) 18 oz bottles, 12/18 oz bottles per case, 5063-432-02; b) 1 gallon bottles, 4/1 gallon bottles per case, 5063-420-03; c) Options Systems Antibacterial Foaming Hand Wash with .3% PCMX, packaged in 1000mL pouches, 6/1000ML pouches per case, 5063-OS1000; d) INOFOAM Antibacterial Foaming Hand Wash with .3% PCMX, packaged in 1000mL pouches, 6-1000ml pouches per case, 5063-FL1000, Inopak LTD., 24 Executive Parkway, Ringwood, NJ 07456. | CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices. | Inopak Ltd / 17,850 pounds per batch | Class II | Terminated |
| D-1311-2019 | 04-22-2019 | AQUACIL instant foaming hand sanitizer, alcohol free formula, benzalkonium chloride 0.1% (w/w), packaged in a) 18 FL OZ (532 mL) bottles, 12/18OZ bottles per case, Product Code BIO-5075-432-02; b) 1000 ML pouches, 6/1000 ML pouches per case, Product Code BIO575-OS1000, Biocentris Pharmaceuticals (Division of Inopak). | CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices. | Inopak Ltd / 17,850 pounds per batch | Class II | Terminated |
| D-1319-2019 | 04-22-2019 | Unison Hand Care Products, WHITE PEARLIZED Anti-Bacterial Hand Cleaner with Triclosan, #4302, with exclusive Bajan fragrance, packaged in 800 ML (27 FL OZ) pouch containers, 12-800 ml containers/12-27 FL. OZ. container pouches per case, National Chemical Laboratories, Inc., 401 North 10th Street, Philadelphia, PA 19123. | CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices. | Inopak Ltd / 17,850 pounds per batch | Class II | Terminated |
| D-1318-2019 | 04-22-2019 | Antibacterial Hand Soap, .3% P.C.M.X, labeled as STYLE Antibacterial Hand Soap with moisturizers, a) 1000 ml pouches, 10/1000 ML. Large Valve pouches per case, 5031-404-LN, b) 1000 ml pouches, 8/1000 ML. Disc Pumps pouches per case, 5031-L1000, c) 800 ML Universal Valve pouches, 12/800 ML Universal Valve pouches per case, 5031-404, d) 800 ml pouches, 12/800 ML Presspak pouches per case, "B", 5031-403-1B, e) 800 ml pouches, 12 x 800ML. KC Valve pouches per case, 5031-404-KC, f) 800 ml pouches, 12/800 ML Universal Valve pouches per case, 5031-404, g) 800 ml pouches, 12/800 ML Presspak pouches per case, "B", 5031-403-1B, h) 500 ml pouches, 6/500 ML. KC Valve pouches per case, 5031-404-500-6, i) 500 ml pouches, 18/500 ML. KC Valve pouches per case, 5031-404-500, j) 500 ml pouches, 6/500 ML. KC Valve pouches per case, 5031-404-500-6, k) 8 oz. bottles, 24/8 OZ. bottles with pumps per case, 5031-440-03, l) 18 oz. bottles, 16 x 18 OZ. Bottles with Pumps per case, 5031-430-02, m) 1000 ml pouches, 10/1000 ML. Large Valve pouches per case, 5031-404-LN, n) 1000 ml pouches, 8/1000ML. Disc Pumps pouches per case, 5031-L1000; Choice Antibacterial Hand Soap, packaged as o) 800 ml/27fl.oz. pouches, 12/800 ml Universal Valve pouches per case, 5031-404UV-CH, Manufactured by Inopak LTD., Ringwood, NJ. | CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices. | Inopak Ltd / 17,850 pounds per batch | Class II | Terminated |
| D-1277-2019 | 04-19-2019 | FENTANYL Transdermal System, 12 mcg/h, five (12 mcg/h) systems per carton, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058; Manufactured by: 3M Drug Delivery Systems, St. Paul, MN 55107, NDC 47781-423-47. Package NDCs: 47781-423-11; 47781-423-47; 47781-424-11; 47781-424-47; 47781-426-11; 47781-426-47; 47781-427-11; 47781-427-47; 47781-428-11; 47781-428-47 | Product Mix-Up: Customer complaint that their carton labeled as Fentanyl Transdermal Systems, 12 mcg/h contained five patches labeled and containing 50 mcg/h. | Alvogen, Inc / 119,608 cartons | Class I | Terminated |
| D-1271-2019 | 04-19-2019 | BEVACIZUMAB 1.25 mg/0.05 mL 31G MJ syringe Intravitreal Injection. This biologic product was repackaged by AmEx Pharmacy 1515 Elizabeth St. Suite J Melbourne, FL 32901 Lot:190212AB BUD:5/13/2019, Repackaged on 2/12/2019 | Defective Delivery System: difficult to express | Pacifico National, Inc. dba AmEx Pharmacy / 249 syringes | Class II | Terminated |
| D-1266-2019 | 04-18-2019 | Losartan Potassium Tablets, USP, 100 mg, a) 90-count (NDC: 13668-115-90), b)1000-count (NDC: 13668-115-10) per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level. | Torrent Pharma Inc. / 65,184 bottles | Class II | Ongoing |
| D-1265-2019 | 04-18-2019 | Losartan Potassium Tablets, USP, 50 mg, a) 90-count (NDC: 13668-409-90), b)1000-count (NDC: 13668-409-10) per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level. | Torrent Pharma Inc. / 164,424 bottles | Class II | Ongoing |
| D-1264-2019 | 04-18-2019 | Losartan Potassium Tablets, USP, 25 mg, a) 90-count (NDC: 13668-113-90), b)1000-count (NDC: 13668-113-10) per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level. | Torrent Pharma Inc. / 28,464 bottles | Class II | Ongoing |
| D-1267-2019 | 04-18-2019 | Losartan Potassium and Hydrochlorothiazide Tablets, USP, 50mg/12.5mg, a) 30-count (NDC: 13668-116-30), b) 90-count (NDC: 13668-116-90), c) 1000-count (NDC: 13668-116-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level. | Torrent Pharma Inc. / 331,764 bottles | Class II | Ongoing |
| D-1269-2019 | 04-18-2019 | Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/25mg, a) 30-count (NDC: 13668-118-30) b) 90-count (NDC: 13668-118-90), c) 1000-count (NDC: 13668-118-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level. | Torrent Pharma Inc. / 239,016 bottles | Class II | Ongoing |
| D-1268-2019 | 04-18-2019 | Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/12.5mg, a) 90-count (NDC: 13668-117-90), b) 1000-count (NDC: 13668-117-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level. | Torrent Pharma Inc. / 54,084 bottles | Class II | Ongoing |
| D-1136-2019 | 04-15-2019 | Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx Only, Manufactured for Daxor Corp., NY, NY; By: Iso-Tex Diagnostics, Inc.; NDC 50914-7720-8. Package NDCs: 50914-7720-8 | Lack of Assurance of Sterility: environmental monitoring report exceeds limits, therefore sterility cannot be assured. | Iso-Tex Diagnostics, Inc / 54 1ml syringes | Class II | Terminated |
| D-1215-2019 | 04-12-2019 | Magnesium Sulfate 4 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / 3007 bags | Class II | Terminated |
| D-1211-2019 | 04-12-2019 | Diltiazem 250 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / 1475 bags | Class II | Terminated |
| D-1212-2019 | 04-12-2019 | Labetalol 20 mg/4 mL, 20 mg in 4 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / 6667 syringes | Class II | Terminated |
| D-1213-2019 | 04-12-2019 | Magnesium Sulfate 1 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / 2162 bags | Class II | Terminated |
| D-1238-2019 | 04-12-2019 | Vancomycin 1750 mg in 0.9% Sodium Chloride 500 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / 118 bags | Class II | Terminated |
| D-1225-2019 | 04-12-2019 | CeFAZolin 2 GM a) in NS 100 mL bag; b) 100 mg/mL (20 mL) syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / a) 1357 bags; b) 6895 syringes | Class II | Terminated |
| D-1235-2019 | 04-12-2019 | Vancomycin 1000 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / 532 bags | Class II | Terminated |
| D-1205-2019 | 04-12-2019 | Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in (a) 150 mL bottle (NDC 0093-4150-80) (b) 80 mL bottle (NDC 0093-4150-79), Rx Only, Manufactured in Canada By: Teva Canada Limited Toronto, Canada, M1B2K9, Manufactured For: Teva Pharmaceuticals USA, INC. North Wales, PA 19454. | Subpotent Product: assay results for Amoxicillin were below the specification limits. | Teva Pharmaceuticals USA / 171,488 150 mL and 80 mL bottles | Class II | Terminated |
| D-1233-2019 | 04-12-2019 | Sodium Bicarbonate 150 mEq in D5W 1000 mL bags, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / 100 bags | Class II | Terminated |
| D-1234-2019 | 04-12-2019 | Sodium Citrate 4%, 40 mg/mL, 3 mL syringe, Flush Syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / 40 syringes | Class II | Terminated |
| D-1227-2019 | 04-12-2019 | CefTRIAXone 1 GM, 100 mg/mL, 10 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / 15 syringes | Class II | Terminated |
| D-1221-2019 | 04-12-2019 | Lidocaine Buffered with J-Tip 0.25 mL, 1 mL syringe, 10:1, For Intradermal Use Only, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / 705 syringes | Class II | Terminated |
| D-1210-2019 | 04-12-2019 | Clindamycin 900 mg in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / 1233 bags | Class II | Terminated |
| D-1236-2019 | 04-12-2019 | Vancomycin 1250 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / 737 bags | Class II | Terminated |
| D-1216-2019 | 04-12-2019 | Magnesium Sulfate 6 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / 196 bags | Class II | Terminated |
| D-1214-2019 | 04-12-2019 | Magnesium Sulfate 2 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / 6746 bags | Class II | Terminated |
| D-1219-2019 | 04-12-2019 | Oxytocin 30 units in NS 500 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / 3690 bags | Class II | Terminated |
| D-1240-2019 | 04-12-2019 | DelNido Cardioplegia (Normosol-R pH 7.4 or Plasma-Lyte A pH 7.4 1000 mL bag) Mannitol 20%-16.3 mL, Potassium Chloride 2 meq/mL-13 mL, Sodium Bicarbonate 8.4%-Lidocaine 1%-1:1 Dilution-26 mL, Magnesium Sulfate 500 mg/mL-4 mL, Cardiac Perfusion Only - Not for IV Use, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / 110 bags | Class II | Terminated |
| D-1224-2019 | 04-12-2019 | CeFAZolin 1 GM a) in NS 100 mL bag; b) 100 mg/mL (10 mL) syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / a) 150 bags; b)1369 syringes | Class II | Terminated |
| D-1226-2019 | 04-12-2019 | CeFAZolin 3 gm 100 mg/mL, 30 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / 475 syringes | Class II | Terminated |
| D-1209-2019 | 04-12-2019 | Dexmedetomidine 400 mcg in NS 100 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / 5678 bags | Class II | Terminated |
| D-1230-2019 | 04-12-2019 | Phenylephrine 0.8 mg/10 mL NS (0.08 mg/mL), (80 mcg/mL) syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / 1310 syringes | Class II | Terminated |
| D-1239-2019 | 04-12-2019 | Vancomycin 2000 mg in 0.9% Sodium Chloride 500 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / 532 bags | Class II | Terminated |
| D-1222-2019 | 04-12-2019 | Lidocaine 1% - Sodium Bicarb 8.4% 10:1, 10 mL syringe, For Intradermal Use Only, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / 40 syringes | Class II | Terminated |
| D-1232-2019 | 04-12-2019 | Phenylephrine 40 mg in 0.9% Sodium Chloride 250 mL bag, 160 mcg/mL, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / 215 bags | Class II | Terminated |
| D-1231-2019 | 04-12-2019 | Phenylephrine 20 mg NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / 390 bags | Class II | Terminated |
| D-1218-2019 | 04-12-2019 | Norepinephrine 16 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / 2567 bags | Class II | Terminated |
| D-1237-2019 | 04-12-2019 | Vancomycin 1500 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / 715 bags | Class II | Terminated |
| D-1223-2019 | 04-12-2019 | Lidocaine 1% - Sodium Bicarbonate 8.4% 1:1, 1 mL syringe, For Intradermal Use Only, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / 1135 syringes | Class II | Terminated |
| D-1217-2019 | 04-12-2019 | NICARdipine 25 mg in NS 250 mL EXCEL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / 1783 bags | Class II | Terminated |
| D-1229-2019 | 04-12-2019 | Heparin Pork 30,000 Units in NS 1000 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / 87 bags | Class II | Terminated |
| D-1228-2019 | 04-12-2019 | Chlorothiazide 100 mg, 3.57 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / 60 syringes | Class II | Terminated |
| D-1220-2019 | 04-12-2019 | Alteplase 1 mg/mL 1 mL in 10 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / 97 syringes | Class II | Terminated |
| D-1133-2019 | 04-11-2019 | Divalproex Sodium Extended-Release Tablets, USP, 250 mg a) 100-count bottle (NDC 55111-0533-01), b) 500-count bottle (NDC 55111-0533-05), Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally, - 500 090 INDIA | cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations. | Dr. Reddy's Laboratories, Inc. / 33,958 bottles | Class II | Terminated |
| D-1243-2019 | 04-10-2019 | Morphine Sulfate Extended-Release Tablets, 15 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, NDC 43386-540-01 Package NDCs: 43386-540-01; 43386-540-05; 43386-541-01; 43386-541-05; 43386-542-01; 43386-542-05; 43386-543-01; 43386-543-05; 43386-544-01; 43386-544-05 | Failed Impurities/Degradation Specifications | LUPIN SOMERSET / 17,328 bottles | Class III | Terminated |
| D-1247-2019 | 04-10-2019 | Morphine Sulfate Extended-Release Tablets, 200 mg Rx Only 100 Tablets Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-544-01 Package NDCs: 43386-540-01; 43386-540-05; 43386-541-01; 43386-541-05; 43386-542-01; 43386-542-05; 43386-543-01; 43386-543-05; 43386-544-01; 43386-544-05 | Failed Impurities/Degradation Specifications | LUPIN SOMERSET / 324 bottles | Class III | Terminated |
